A UNIT OF THE MEDICAL SCHOOL OFFICE OF RESEARCH

June 15, 2017 

Dear Colleagues,
As we progress through the summer, our Clinical Trials Support Units are busy managing the pre- and post-award for 197 new trials in the OnCore Clinical Trials Management System. Several are also supporting study coordination. We have started the stabilization phase of the OnCore project, an exciting time that allows us to focus on new trials while continuing to engage study teams and department staff with our new processes. The OnCore Team now also offers at-the-elbow support - see more information below.
 
Concurrently, the first "Instruction in Monitoring, Protocols, and Advanced Documentation in Clinical Trials" (IMPACT) series took place in May. In partnership with MICHR, the instructional series is designed for faculty, study coordinators with two or more years of experience, and other study team members who are ready for an intermediate level of training for clinical research skills.
 
We look forward to another productive month. Many thanks for your continued partnership.

Best regards,
Anna Lok, M.D.
Assistant Dean for Clinical Research
aslok@umich.edu

Latest clinical trial support activities:

nihFinalized NIH-FDA Protocol Template Released
Many Michigan Medicine investigators and study teams have been utilizing a draft version of the National Institutes of Health (NIH) protocol template. The NIH recently released the Final NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies. The template aims to assist NIH-funded investigators in preparing clinical trial documents efficiently so that both IRBs and the FDA can perform speedy reviews. NIH has also released a web-based platform where investigators can utilize the protocol template in an interactive fashion. The Electronic Protocol Writing Tool allows for a collaborative approach to writing and reviewing protocols. Investigators will be able to use the tool to form a "protocol writing team" and assign different individuals with writing and reviewing roles. All of the above resources can be found on the OSP website.

To learn more about the importance of these new resources, read the latest Under the Poliscope blog by the NIH Associate Director for Science Policy, Dr. Carrie D. Wolinetz. For an additional perspective, please also see the statement released by NIH Director, Dr. Francis Collins.

Links to these NIH resources, as well as others, are available at Clinical Trials Support Office website . Questions? Contact ctsogroup@umich.edu.

oneOne-on-One Support for OnCore Users
There are now 197 new trials in OnCore, and 223 individuals have received OnCore training!

The Clinical Trials Support Units (CTSUs) and OnCore Team have made the conscious decision to focus on new trials. After pausing to evaluate how things were going and seeking input from study teams, departments, and other key stakeholders, we have decided to target more efficient activation of new trials before migrating additional existing trials into the CTSUs and OnCore. 

Informed by thoughtful feedback from many of you, we are implementing a "stabilization" period in the clinical trials transformation to clarify processes, tighten up our practices, enhance our customer service to study teams and departments, retool our training, and build more real-time experience with the OnCore system. This stabilization period is intended to allow us to better serve our research community.   

The OnCore Team is working closely with study teams, departments, and CTSUs as we continue to drive improvements to clinical trials processes and future migration trial migrations. Have a question? Need at-the-elbow support while you go through a new process? End-users can schedule a one-on-one at their desks or via teleconference with the OnCore Trainers and support team if they have any questions or would benefit from any kind of assistance. Email clinical-support-service-desk@med.umich.edu, subject "OnCore" - we're happy to help!

griebGrieb Wins Staff Innovation Award for Work on Clinical Trials Initiative
Teri Grieb, Senior Director for Research in the Medical School Office of Research, was awarded the individual 2017 President's Staff Innovation Award! Teri received the award for innovation in our clinical trials initiative. For more information about this year's awards, read the article . 
 
Many thanks and congratulations also goes out to all of the staff who have worked tirelessly to streamline the clinical trials process!

trainingTraining & Events


Protocol Maintenance
June 21*8:30AM-10:00AM
Subject Lifecycle Management
June 21*10:30AM-12:00PM
Subject Visit Management
June 21*1:00PM-12:30PM
NCRC Building 300, Room 371 is the location for all three sessions on June 21. 

Pre-Award
June 22*8:30AM-10:00AM
Post-Award
June 22*10:30AM-12:30PM
Protocol Administration
June 22*1:30PM-3:00PM
Protocol Maintenance
June 22*3:30PM-5:00PM
NCRC Building 300, Room 371 is the location for all four sessions on June 22.

The "Research Basics" workshop series is designed to introduce research team members who have less than two years of research experience, or who are new to research at U-M, to basic concepts in clinical research. Sessions are listed below - registration is required CLICK HERE .

Fundamentals of Data Management
June 23*2:00PM-4:30PM*Danto Auditorium, CVC

Essential Documents and Good Clinical Practice
June 29*2:00PM-4:30PM*Danto Auditorium, CVC

Conducting and Obtaining Valid Informed Consent
July 10*2:00PM-4:30PM*Danto Auditorium, CVC

spotlightClinical Trials Spotlight
Making a difference with children who suffer from brain tumors
"I've been working on two investigator-initiated trials and two multi-site trials with the Children's Clinical Trial Support team, including Nick Harris and Alyssa Paul, Clinical Research Project Manager and Clinical Subjects Coordinator.

Most of my pediatric brain tumor patients in need of chemotherapy at U-M will likely have an opportunity to participate in a trial going forward because of your pre-award, post-award, and study coordinator support. That means a lot for not only for me, but the neuro-oncology program, and most importantly, the patients and their families. Accomplishments like this tend to get lost in the metrics, so I wanted to share it with you. Nice job, everyone!"

Carl Koschmann, M.D.
Pediatric Neuro-Oncology, Division of Pediatric Hematology-Oncology

For more information about the Clinical Trials Support Office, CLICK HERE.
Our mission in the Clinical Trials Support Office is to support faculty and staff at the University of Michigan Medical School as they work to create the new knowledge needed to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials.